Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale and Perfusion Index

Haydarpasa Numune Training and Research Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Topical Analgesia; Blood Gas Analysis

Treatments: Drug: Lidocaine spray; Drug: Diclofenac; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06918340

2024-KAEK-64

Details and patient eligibility

About

The aim of this clinical trial is to evaluate the analgesic efficacy of lidocaine and diclofenac sprays to be administered before the procedure in cases admitted to the emergency department and requiring radial artery blood gas sampling by means of visual pain scale (VAS) and perfusion index in comparison with placebo. The main questions it aims to answer are:

1. Is there a difference between the efficacy of two different sprays? 2. Is there a significant difference between the side effects of two different sprays? Researchers will compare diclofenac sodium, lidocain and placebo sprays. Treatments will;

2. be administered in same three spray bottles to ensure blinding in the groups.

3. Randomisation will be done by closed envelope method.

4. Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the sprays. NRS scores will be recorded in both groups before starting blood gas sampling (baseline) and after blood gas sampling.

5. Any side effects due to medication will be recorded.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being between the ages of 18-65.
• Having clinical indication for radial artery blood gas sampling
• Being conscious, co-operative and orientated
• Those who approved the informed consent form

Exclusion criteria

• Being under 18 years of age.
• Being pregnant or breastfeeding.
• Not being conscious, co-operative and orientated (impaired consciousness)
• Being used painkillers in the last 24 hours
• Radial artery blood gas sampling on the same day (more than one application)
• Presence of cardiac arrhythmia
• Have a diagnosis of neuropathy (including diabetic neuropathy)
• Having a diagnosis of anxiety and panic disorder
• Using a sustained-release dermal analgesic patch (fentanyl)
• Patient unable to comply with the visual analogue pain scale (VAS) due to language barrier
• Presence of a condition such as dementia, etc. that may lead to a change in consciousness
• Allergy to lidocaine or diclofenac

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

Group I: 5-6 puffs of topical 10% lidocaine spray

Active Comparator group

Description:

Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling.

Treatment:

Drug: Lidocaine spray

Group II: topical 1% diclofenac spray

Active Comparator group

Description:

Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling.

Treatment:

Drug: Diclofenac

Group III: topical 70% alcohol solution spray

Placebo Comparator group

Description:

Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling.

Treatment:

Other: Placebo